protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05014568 | 5.6.1 | Permitted Medications and Nondrug Therapies | 5.6.1 Permitted Medications and Nondrug Therapies Concomitant medications for medical treatment of other conditions are allowed under the condition that the dosage and administration of these treatments is not planned to change from the Baseline visit to the completion of the treatment phase (Week 8) and that the medic... | [] |
NCT05014568 | 5.6.2 | Prohibited Medications and Nondrug Therapies | 5.6.2 Prohibited Medications and Nondrug Therapies Medications and nondrug therapies that are prohibited throughout the study duration are described in the Exclusion Criteria (Section 4.3). A list of prohibited medications, emollients and nondrug therapies may be provided as a separate document. If a subject chooses to... | [] |
NCT05014568 | 6 | Study Assessments and Procedures | 6 Study Assessments and Procedures Study procedures and assessments are summarized in the Schedule of Assessments and in Section 7. Adherence to the study design requirements, including those specified in the Schedule of Assessments (Table 1) are essential and required for study conduct. Protocol waivers or exemptions ... | [] |
NCT05014568 | 6.1 | Demography, Medical History, and Baseline Characteristics | 6.1 Demography, Medical History, and Baseline Characteristics | [] |
NCT05014568 | 6.1.1 | Demographics | 6.1.1 Demographics Demographic information collected will include age, sex, race, ethnicity, and Fitzpatrick skin type. Information on Fitzpatrick skin type can be found in Appendix 2. | [] |
NCT05014568 | 6.1.2 | Medical History | 6.1.2 Medical History Medical history will be collected to ensure subjects are eligible for participation in the study (per inclusion Section 4.2 and exclusion Section 4.3 criteria). Data collected will include year of AD diagnosis, allergic conditions, cardiovascular (CV) medical history and risk factors (including he... | [] |
NCT05014568 | 6.2 | Efficacy Assessments | 6.2 Efficacy Assessments To minimize inter-observer variability, Investigators and evaluators/raters will be trained on each of the required assessments during an Investigator meeting, site initiation visit, and/or utilizing online assessments before enrolling subjects at their study site. Only trained evaluators/rater... | [] |
NCT05014568 | 6.2.1 | Assessments Completed by Investigator | 6.2.1 Assessments Completed by Investigator | [] |
NCT05014568 | 6.2.1.1 | Validated Investigator Global Assessment of Atopic Dermatitis | 6.2.1.1 Validated Investigator Global Assessment of Atopic Dermatitis The vIGA-AD™ of disease severity will be assessed at every clinic visit. The vIGA-AD™ is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity (scalp excluded) and will be determ... | [] |
NCT05014568 | 6.2.1.2 | Body Surface Area Affected | 6.2.1.2 Body Surface Area Affected | [] |
NCT05014568 | 6.2.1.3 | Eczema Area and Severity Index | 6.2.1.3 Eczema Area and Severity Index | [] |
NCT05014568 | 6.2.2 | Assessments Completed by Subject or Caregiver | 6.2.2 Assessments Completed by Subject or Caregiver  | [] |
NCT05014568 | 6.2.2.3 | Peak Pruritus-Numeric Rating Scale | 6.2.2.3 Peak Pruritus-Numeric Rating Scale The PP-NRS is a scale used to quickly assess itch/pruritus severity over a 24-hour period. The subject or caregiver will utilize the scale to assess peak pruritus QD and record the results in their daily diaries. The itch rating can be done before or after study drug administr... | [] |
NCT05014568 | 6.2.3 | Optional Clinical Photography | 6.2.3 Optional Clinical Photography Clinical photography may be performed in a subgroup of subjects at selected study sites. Informed consent/assent and photographic release will be required. The photographs may not be referred to by the Investigator at any subsequent study visit for the purposes of grading. Photograph... | [] |
NCT05014568 | 6.3 | Safety Assessments | 6.3 Safety Assessments | [] |
NCT05014568 | 6.3.1 | Adverse Events | 6.3.1 Adverse Events All AEs and SAEs will be collected from the time the subject signs the informed consent form (ICF) until the final visit/contact with the subject. Additional safety information, including the definition of an AE and the methods for recording, evaluating, and assessing causality of AEs and the proce... | [] |
NCT05014568 | 6.3.2 | Brief Physical Examination | 6.3.2 Brief Physical Examination A brief physical examination will include, at a minimum, assessments of the skin, lungs, CV system, and abdomen (liver and spleen). Assess for changes in onset of menses (female participants) or sexual activity (male or female participants). Determine if there is a need for contraceptio... | [] |
NCT05014568 | 6.3.3 | Vital Signs | 6.3.3 Vital Signs Vital signs will be measured before blood collection for clinical laboratory assessments and PK analysis (where applicable) and will include measurements of systolic and diastolic blood pressure, pulse rate, and body temperature. Subjects should be in a seated position for at least 5 minutes before vi... | [] |
NCT05014568 | 6.3.4 | Clinical Safety Laboratory Assessments | 6.3.4 Clinical Safety Laboratory Assessments All protocol-required laboratory assessments must be conducted in accordance with the Study Reference Manual or Laboratory Manual and the protocol Schedule of Assessments (Table 1). Laboratory requisition forms must be completed, and samples must be clearly labeled with the ... | [] |
NCT05014568 | 6.3.5 | Electrocardiograms | 6.3.5 Electrocardiograms Single 12-lead ECGs will be obtained at a subset of sites in a subset of subjects at timepoints indicated in the Schedule of Assessments (Table 1) and Section 7 using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Subjects should be in a... | [] |
NCT05014568 | 6.3.6 | Local Tolerability Scale | 6.3.6 Local Tolerability Scale | [] |
NCT05014568 | 6.3.6.1 | Investigator-Assessed Local Tolerability Scale | 6.3.6.1 Investigator-Assessed Local Tolerability Scale At each specified study visit, the Investigator (or qualified evaluator) will assess the presence and overall degree of irritation at the application sites, according to a 5-point LTS. The score will ideally represent an "average" across all application sites. To t... | [] |
NCT05014568 | 6.3.6.2 | Subject (or Caregiver)-Assessed Local Tolerability Scale | 6.3.6.2 Subject (or Caregiver)-Assessed Local Tolerability Scale At each specified study visit, the subject or caregiver will separately assess the presence and degree of burning/stinging and itching at the application sites, each according to a 5-point LTS. The subject or caregiver will not score each sensitive area i... | [] |
NCT05014568 | 6.4 | Treatment of Study Drug Overdose | 6.4 Treatment of Study Drug Overdose For this study, accidental or intentional oral ingestion of drug product will be considered an overdose. Ingestion of a 30-gram tube of tapinarof cream, 1% would result in an oral dose of 300 mg. The Sponsor does not recommend specific treatment for an overdose; however, in the even... | [] |
NCT05014568 | 6.5 | Pharmacokinetics | 6.5 Pharmacokinetics Blood samples for PK analysis of tapinarof concentration will be collected at a subset of sites in a subset of subjects at timepoints indicated in the Schedule of Assessments (Table 1) and Section 7. The actual date and time of each blood sample collection will be recorded as well as the date and t... | [] |
NCT05014568 | 6.6 | Virtual Assessments | 6.6 Virtual Assessments In the event that a subject cannot attend their regularly scheduled study visits in person due to a COVID-19 like situation necessitating a limit on in-person contact, the Investigator may perform safety and efficacy assessments by phone or video. Source documentation should note if the visit wa... | [] |
NCT05014568 | 7 | Timing of Procedures and Assessments | 7 Timing of Procedures and Assessments This section lists the procedures and assessment to be performed at scheduled timepoints during the study as outlined in the Schedule of Assessments (Table 1). Information on study procedures and assessments is provided in Section 6. - Any change in timing or any addition of a tim... | [] |
NCT05014568 | 7.1 | Visit 1; Screening Period (Day -30 to Day -1) | 7.1 Visit 1; Screening Period (Day -30 to Day -1) After the subject has signed the consent/assent form, potential study subjects will undergo Screening procedures and assessments to confirm eligibility to participate in the study. Screening assessments will include the following: - Demography recording - Fitzpatrick sk... | [] |
NCT05014568 | 7.2 | Visit 2; Baseline (Day 1) | 7.2 Visit 2; Baseline (Day 1) On Day 1, subjects will be reassessed to confirm continued eligibility to participate in the study. All subjects who continue to meet study eligibility criteria will be randomized to treatment. The following additional procedures and assessments will be performed at the Baseline Visit: - C... | [] |
NCT05014568 | 7.3 | Visit 3; Week 1 (Day 8 ±2 Days) | 7.3 Visit 3; Week 1 (Day 8 ±2 Days) The following procedures and assessments will be performed at Visit 3: - Vital signs - vIGA-AD™ score (excluding subject's scalp) - %BSA affected calculation (excluding subject's scalp) - EASI (excluding subject's scalp) - • - • PP-NRS - • - • - AE recording - Concomitant medication ... | [] |
NCT05014568 | 7.4 | Visit 4; Week 2 (Day 15 ±2 Days) | 7.4 Visit 4; Week 2 (Day 15 ±2 Days) The following procedures and assessments will be performed at Visit 4: - Vital signs measurement - Photography of a representative area of the subject's disease area (at a subset of study sites only) - AE recording - Concomitant medication recording - vIGA-AD™ score (excluding subje... | [] |
NCT05014568 | 7.5 | Visit 5; Week 4 (Day 29 ±2 Days) | 7.5 Visit 5; Week 4 (Day 29 ±2 Days) The following procedures and assessments will be performed at Visit 5: - Urine pregnancy test (females of child-bearing potential) - Brief physical examination - Vital signs measurement - ECG recording (at a subset of study sites only) - Blood sample collection for clinical laborato... | [] |
NCT05014568 | 7.6 | Visit 6; Week 8 (Day 57 ±2 Days) | 7.6 Visit 6; Week 8 (Day 57 ±2 Days) The following procedures and assessments will be performed at Visit 6: - Urine pregnancy test (females of child-bearing potential) - Brief physical examination - Vital signs measurement - Blood sample collection for clinical laboratory tests (serum chemistry, hematology, diagnostic ... | [] |
NCT05014568 | 7.7 | Phone Contact at Weeks 3 (Day 22 ±2 Days) and 6 (Day 43 ±2 Days) | 7.7 Phone Contact at Weeks 3 (Day 22 ±2 Days) and 6 (Day 43 ±2 Days) Subjects or their caregivers will be contacted by phone at Weeks 3 and 6 to review study drug application instructions and to record AEs and concomitant medication use. Subjects should be reminded to complete their daily diary and bring it with them t... | [] |
NCT05014568 | 7.8 | Follow-Up Visit 7; Week 9 (Day 64 ±2 Days) | 7.8 Follow-Up Visit 7; Week 9 (Day 64 ±2 Days) Subjects who complete Visit 6/Week 8 but do not enroll in the OL-LTE study will return to the study site at Week 9 to complete Follow-Up assessments as follows: • Brief physical examination - Vital signs measurement - If needed, blood sample collection for clinical laborat... | [] |
NCT05014568 | 7.9 | Early Termination Visit | 7.9 Early Termination Visit Subjects who withdraw early from the study will be asked to return to the study site to complete Early Termination assessments as follows: - Urine pregnancy test (females of child-bearing potential) - Brief physical examination - Vital signs measurement - Blood sample collection for clinical... | [] |
NCT05014568 | 7.10 | Unscheduled Visit | 7.10 Unscheduled Visit Subjects may have an unscheduled visit for AE follow-up, study drug dispensation, make-up for a missed visit, or other reason. The following assessments may be performed: - Urine pregnancy test (females of child-bearing potential) - Brief physical examination - Vital signs measurement - Blood sam... | [] |
NCT05014568 | 7.11 | End of Study | 7.11 End of Study The end of study is defined as when the last active subject has completed the Week 9 Follow-up Visit which is 1 week after the end of treatment (if subject does not enroll in the OL-LTE study) OR the last active subject has completed the 8 weeks of treatment in this study (if subject is eligible and e... | [] |
NCT05014568 | 8 | Safety Monitoring and Reporting | 8 Safety Monitoring and Reporting | [] |
NCT05014568 | 8.1 | Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | 8.1 Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest The Investigator or site staff is responsible for detecting, documenting, and reporting events that meet the definition of an AE, SAE, or AESIs. At each visit/contact, subjects should be questioned in a general way so as not to introduce... | [] |
NCT05014568 | 8.1.1 | Definition of Adverse Events | 8.1.1 Definition of Adverse Events An AE is any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether considered causally related or not related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory fi... | [] |
NCT05014568 | 8.1.2 | Definition of Serious Adverse Event | 8.1.2 Definition of Serious Adverse Event If an event is not an AE per Section 8.1.1, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease, etc.). An SAE is any untoward medical occurrence that, at any dose:... | [] |
NCT05014568 | 8.1.3 | Adverse Events of Special Interest | 8.1.3 Adverse Events of Special Interest In prior clinical studies, contact dermatitis, folliculitis, and headache have been identified as AEs of particular clinical importance and will be reported as AESIs in this study whether or not the AE is considered related to study drug. In each case study drug may be continued... | [
"Contact Dermatitis",
"Headache",
"Follicular Event"
] |
NCT05014568 | 8.2 | Classification of Adverse Events | 8.2 Classification of Adverse Events | [] |
NCT05014568 | 8.2.1 | Assigning Severity Rating for Adverse Events | 8.2.1 Assigning Severity Rating for Adverse Events | [] |
NCT05014568 | 8.2.1.1 | Criteria for Determining Adverse Event Severity | 8.2.1.1 Criteria for Determining Adverse Event Severity The Investigator will make an assessment of the severity of each AE and SAE according to the National Cancer Institute CTCAE, v. 5.0, 2017. For terms not specified with the CTCAE, the criteria in Table 5 should be used to determine the grade severity. Table 5: Cri... | [] |
NCT05014568 | 8.2.1.2 | Toxicity Management Criteria | 8.2.1.2 Toxicity Management Criteria | [] |
NCT05014568 | 8.2.1.2.1 | Grade 1 or Grade 2 Adverse Event | 8.2.1.2.1 Grade 1 or Grade 2 Adverse Event Subjects who develop a Grade 1 or Grade 2 AE may continue investigational product at the discretion of the Investigator. Subjects who choose to withdraw from study due to a Grade 1 or 2 AE should have study withdrawal/early termination evaluations completed. | [] |
NCT05014568 | 8.2.1.2.2 | Grade 3 Adverse Event | 8.2.1.2.2 Grade 3 Adverse Event Subjects who develop a Grade 3 AE should be managed as follows: - If the Investigator has compelling evidence that the Grade 3 AE has not been caused by investigational product, then dosing may continue after discussion with the Medical Monitor. - Subjects who develop a Grade 3 AE that t... | [] |
NCT05014568 | 8.2.1.2.3 | Grade 4 Adverse Event | 8.2.1.2.3 Grade 4 Adverse Event Subjects who develop a Grade 4 AE should have investigational product permanently discontinued. Subjects experiencing Grade 4 AEs requiring permanent discontinuation of investigational product should be followed weekly until resolution or stability of the AE and encouraged to have withdr... | [] |
NCT05014568 | 8.2.1.2.4 | Folliculitis | 8.2.1.2.4 Folliculitis Subjects using tapinarof topically may experience folliculitis. The majority of these events are mild or moderate and do not require intervention or interruption in study drug use. On close inspection, the morphology is similar to that of keratosis pilaris suggesting that the potential mechanism ... | [] |
NCT05014568 | 8.2.1.2.5 | Other Management Criteria: | 8.2.1.2.5 Other Management Criteria: The Medical Monitor should be notified if any of the following occur: • Severe signs or symptoms, or significant changes in any of the safety assessments, that put the safety of the subject at risk (e.g., laboratory tests or vital signs, etc.) as judged by the Investigator. | [] |
NCT05014568 | 8.2.2 | Assigning Causal Relationship to Study Drug | 8.2.2 Assigning Causal Relationship to Study Drug The Principal Investigator or sub-Investigator is to make the causality assessment. The reasonable possibility of the relationship of an AE to study drug is to be assessed with careful medical consideration at the time of evaluation of an AE. The following definitions a... | [] |
NCT05014568 | 8.3 | Time Period and Frequency for Event Assessment and Follow-Up | 8.3 Time Period and Frequency for Event Assessment and Follow-Up | [] |
NCT05014568 | 8.3.1 | Adverse Event Reporting | 8.3.1 Adverse Event Reporting All AEs will be collected from the time of signed informed consent until the final visit. Any AEs assessed as related to study participation (e.g., protocol-mandated procedures, invasive tests, or change in existing therapy) will be collected from the time a subject consented to participat... | [] |
NCT05014568 | 8.3.2 | Follow-Up of Adverse Events | 8.3.2 Follow-Up of Adverse Events After the initial AE/SAE report, the Investigator is required to proactively follow each subject at subsequent visits/contacts. All SAEs and nonserious AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or if the subject is lo... | [] |
NCT05014568 | 8.4 | Reporting Procedures | 8.4 Reporting Procedures | [] |
NCT05014568 | 8.4.1 | Serious Adverse Event Reporting | 8.4.1 Serious Adverse Event Reporting When an Investigator determines that an AE meets the protocol definition of an SAE during the study, he/she must notify the Sponsor using an SAE Report Form within 24 hours of the study site personnel's knowledge of the event, regardless of the Investigator assessment of the relati... | [] |
NCT05014568 | 8.4.2 | Regulatory Reporting Requirements for Serious Adverse Events | 8.4.2 Regulatory Reporting Requirements for Serious Adverse Events Prompt notification by the Investigator to the Sponsor of SAEs (even for non-interventional post-marketing studies) is essential so that legal obligations and ethical responsibilities towards the safety of subjects and the safety of a product under clin... | [] |
NCT05014568 | 8.5 | Pregnancy Management and Reporting | 8.5 Pregnancy Management and Reporting Any female subject who becomes pregnant during the study will be withdrawn. Details will be collected for all pregnancies in female subjects and female partners of male subjects that begin after the start of dosing and through the Follow-up visit. Pregnancy is not automatically co... | [
"Tapinarof Protocol No.: DMVT-505-3101, Amendment 3 Dermavant Sciences, Inc. Clinical Study Protocol"
] |
NCT05014568 | 9 | Data Management | 9 Data Management For this study, subject data will be entered into the Sponsor-defined CRFs, transmitted electronically to the Sponsor or designee, and combined with data provided from other sources in a validated data system. Management of clinical data will be performed in accordance with applicable Sponsor standard... | [] |
NCT05014568 | 10 | Statistical Considerations and Data Analyses | 10 Statistical Considerations and Data Analyses This study will evaluate the efficacy and safety of tapinarof cream, 1% compared with vehicle control cream in adults and children with AD. | [] |
NCT05014568 | 10.1 | General Considerations | 10.1 General Considerations All study data will be summarized by treatment group using descriptive statistics. Categorical variables will be reported using frequency and percentage (e.g., gender, race). Continuous variables will be reported using number of subjects, mean, standard deviation (SD), median, minimum, and m... | [] |
NCT05014568 | 10.2 | Determination of Sample Size | 10.2 Determination of Sample Size It is estimated that the proportion of subjects who will achieve a vIGA-AD™ score of 0 or 1 and at least a 2 grade reduction from Baseline at Week 8 will be 45% for subjects receiving tapinarof compared with 25% for subjects receiving vehicle control, based upon the Phase 2 results. Wi... | [] |
NCT05014568 | 10.3 | Analysis Populations | 10.3 Analysis Populations | [] |
NCT05014568 | 10.3.1 | Safety | 10.3.1 Safety All randomized subjects who receive at least 1 application of study drug will be included in the Safety population. Subjects will be analyzed as treated. | [] |
NCT05014568 | 10.3.2 | Intent-To-Treat | 10.3.2 Intent-To-Treat All randomized subjects will be included in the Intent-to-treat (ITT) population. Subjects will be analyzed as randomized. | [] |
NCT05014568 | 10.3.3 | Per-Protocol | 10.3.3 Per-Protocol All subjects in the ITT population who did not have any major protocol deviations or other events that may impact the interpretation of the primary efficacy endpoint will be included in the Per Protocol (PP) population. | [] |
NCT05014568 | 10.3.4 | Pharmacokinetic | 10.3.4 Pharmacokinetic All subjects who undergo plasma PK sampling and have evaluable concentration-time data for analysis will be included in the PK population. A sample that is below the quantification limit of the assay is considered evaluable. | [] |
NCT05014568 | 10.4 | Planned Analyses | 10.4 Planned Analyses All efficacy and safety measures over the course of the study will be presented. Details of planned analyses, including the handling of subjects whose visits are impacted by the COVID-19 pandemic, will be described in the Statistical Analysis Plan. | [] |
NCT05014568 | 10.4.1 | Disposition and Demographics | 10.4.1 Disposition and Demographics Demographic and baseline characteristics as well as medical history will be summarized using the ITT population, including frequency and percentages for categorical variables and mean, SD, median, minimum, and maximum for continuous variables. The numbers of subjects in the different... | [] |
NCT05014568 | 10.4.2 | Efficacy Analyses | 10.4.2 Efficacy Analyses All efficacy analyses will be based on the ITT population and will be repeated for the PP population only for the primary and secondary efficacy endpoints as supportive analysis. | [] |
NCT05014568 | 10.4.2.1 | Primary Endpoint Analyses | 10.4.2.1 Primary Endpoint Analyses The primary estimand of interest is the composite estimand in a patient population offered treatment with tapinarof cream, 1% as compared to vehicle (see Table 6). Interest is focused on the treatment effect measured by the ratio of response rates at Week 8. The primary efficacy endpo... | [] |
NCT05014568 | 10.4.2.2 | Secondary and Exploratory Efficacy Endpoint Analyses | 10.4.2.2 Secondary and Exploratory Efficacy Endpoint Analyses The secondary efficacy endpoints are as follows: - Proportion of subjects with ≥ 75% improvement in EASI from Baseline at Week 8 - Mean change in %BSA affected from Baseline at Week 8 - Proportion of subjects with ≥ 90% improvement in EASI from Baseline at W... | [] |
NCT05014568 | 10.4.3 | Safety Analyses | 10.4.3 Safety Analyses The Safety Population will be used in the analysis of safety data. Data will be listed by subject and treatment and summarized by treatment. No formal statistical comparisons will be made for safety data. The number and proportion of subjects with TEAEs will be summarized by treatment, system org... | [] |
NCT05014568 | 10.4.4 | Analysis of Functional Outcomes and Quality of Life Endpoints | 10.4.4 Analysis of Functional Outcomes and Quality of Life Endpoints  | [] |
NCT05014568 | 10.4.5 | Pharmacokinetic Analyses | 10.4.5 Pharmacokinetic Analyses Data will be listed and summarized. Listings will be sorted by subject and day; summaries will be presented by study visit. Unless stated otherwise, descriptive summaries for continuous variables will include n, mean, SD, median, minimum, and maximum. Exploratory analyses may include rel... | [] |
NCT05014568 | 10.5 | Interim Analyses | 10.5 Interim Analyses No interim analyses will be performed. | [] |
NCT05014568 | 10.6 | Handling of Missing Data | 10.6 Handling of Missing Data Every effort will be made to collect complete data at all visits. The primary method of handling of missing data will utilize Multiple Imputations (MI). For sensitivity analysis of the primary and secondary endpoints, Last Observation Carried Forward (LOCF) and Treatment Failure (TF) will ... | [] |
NCT05014568 | 11 | Responsibilities | 11 Responsibilities | [] |
NCT05014568 | 11.1 | Investigator Responsibilities | 11.1 Investigator Responsibilities | [] |
NCT05014568 | 11.1.1 | Good Clinical Practice | 11.1.1 Good Clinical Practice The Investigator will ensure that this study is conducted in accordance with the principles of the "Declaration of Helsinki" (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South Africa), International Conference on Harmonization guidelines, or with the laws and regulations of the ... | [] |
NCT05014568 | 11.1.2 | Institutional Review Board/Independent Ethics Committee Approval | 11.1.2 Institutional Review Board/Independent Ethics Committee Approval This protocol and any accompanying material to be provided to the subject (such as advertisements, subject information sheets, or descriptions of the study used to obtain informed consent) will be submitted by the Investigator or on behalf of the I... | [] |
NCT05014568 | 11.1.3 | Informed Consent/Assent | 11.1.3 Informed Consent/Assent The Investigator is responsible for obtaining written informed consent/assent from each individual participating in this study after adequate explanation of the aims, methods, objectives, and potential hazards of the study and before undertaking any study-related procedures. The Investiga... | [] |
NCT05014568 | 11.1.4 | Confidentiality | 11.1.4 Confidentiality The Investigator must assure that subjects' anonymity will be strictly maintained and that their identities are protected from unauthorized parties. Only subject number, date of birth, and an identification code (i.e., not names) should be recorded on any form or biological sample submitted to th... | [] |
NCT05014568 | 11.1.5 | Study Files and Retention of Records | 11.1.5 Study Files and Retention of Records The Investigator must maintain adequate and accurate records to enable the conduct of the study to be fully documented and the study data to be subsequently verified. These documents should be classified into at least the following 2 categories: (1) Investigator's study file,... | [] |
NCT05014568 | 11.1.6 | Electronic Case Report Forms | 11.1.6 Electronic Case Report Forms For each subject enrolled, a CRF must be completed and signed by the Investigator. This also applies to records for those subjects who fail to complete the study. If a subject withdraws from the study, the reason must be noted on the CRF. If a subject is withdrawn from the study beca... | [] |
NCT05014568 | 11.1.7 | Drug Accountability | 11.1.7 Drug Accountability The Investigator or designee (i.e., pharmacist) is responsible for ensuring adequate accountability of all used and unused investigational medicinal product. This includes acknowledgment of receipt of each shipment of study product (quantity and condition), subject dispensing records, and ret... | [] |
NCT05014568 | 11.1.8 | Inspections | 11.1.8 Inspections The Investigator should understand that source documents for this trial should be made available to appropriately qualified personnel from the Sponsor or its representatives, to IRBs or IECs, or to regulatory authority or health authority inspectors. | [] |
NCT05014568 | 11.1.9 | Protocol Compliance | 11.1.9 Protocol Compliance The Investigator is responsible for ensuring the study is conducted in accordance with the procedures and evaluations described in this protocol. | [] |
NCT05014568 | 11.2 | Sponsor Responsibilities | 11.2 Sponsor Responsibilities | [] |
NCT05014568 | 11.2.1 | Protocol Modifications | 11.2.1 Protocol Modifications Protocol modifications, except those intended to reduce immediate risk to study subjects, may be made only by the Sponsor. All protocol modifications must be submitted to the IRB or IEC and regulatory authorities in accordance with local requirements. Approval must be obtained before chang... | [] |
NCT05014568 | 11.2.2 | Study Report and Publications | 11.2.2 Study Report and Publications A clinical study report will be prepared and provided to the regulatory agency(ies). The Sponsor will ensure that the report meets the standards set out in the ICH Guideline for Structure and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may be prepared... | [] |
NCT05014568 | 11.2.3 | Posting of Information on Publicly Available Clinical Trial Registers | 11.2.3 Posting of Information on Publicly Available Clinical Trial Registers Study information from this protocol will be posted on publicly available clinical trial registers as required by applicable regulations. Results will be posted as required. | [] |
NCT05014568 | 11.3 | Joint Investigator/Sponsor Responsibilities | 11.3 Joint Investigator/Sponsor Responsibilities | [] |
NCT05014568 | 11.3.1 | Access to Information for Monitoring | 11.3.1 Access to Information for Monitoring In accordance with ICH Good Clinical Practice guidelines, the study monitor must have direct access to the Investigator's source documentation in order to verify the data recorded in the CRFs for consistency. The monitor is responsible for routine review of the CRFs at regula... | [] |
NCT05014568 | 11.3.2 | Access to Information for Auditing or Inspections | 11.3.2 Access to Information for Auditing or Inspections To ensure compliance with Good Clinical Practices and all applicable regulatory requirements, Dermavant Sciences, Inc. may conduct a quality assurance audit. Authorized representatives of Dermavant Sciences, Inc., a regulatory authority, an Independent Ethics Com... | [] |
NCT05014568 | 11.3.3 | Study Discontinuation | 11.3.3 Study Discontinuation The Sponsor reserves the right to terminate the study at any time. Should this be necessary, the Sponsor will arrange discontinuation procedures and notify the appropriate regulatory authority(ies), IRBs, and IECs. In terminating the study, the Sponsor and the Investigator will assure that ... | [] |
NCT05014568 | 12 | References | 12 References Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimally clinically important difference and responsiveness of the dermatology life quality index (DLQI): further data. Dermatol. 2015; 230:27-33. Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3:358(14):1483-94. ![](page76Figure... | [
"Tapinarof Protocol No.: DMVT-505-3101, Amendment 3 Dermavant Sciences, Inc. Clinical Study Protocol"
] |
NCT05014568 | 13 | Appendices | 13 Appendices
Appendix 1. Hanifin and Rajka Criteria for Atopic Dermatitis Diagnosis Major Criteria (must have at least three) - Pruritus - Typical morphology and distribution: - − Adults: flexural lichenification or linearity - − Children and infants: involvement of facial and extensor surfaces - Chronic or chronical... | [
"Appendix 1. Hanifin and Rajka Criteria for Atopic Dermatitis Diagnosis",
"Appendix 2. Fitzpatrick Skin Type Scale",
"Tapinarof Protocol No.: DMVT-505-3101, Amendment 3 Dermavant Sciences, Inc. Clinical Study Protocol",
"Appendix 3. Validated Investigator Global Assessment Scale for Atopic Dermatitis",
"Ins... |
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